Kornimate/medical-research-clean huggingface dataset:
safety and efficacy study of osmotic release oral system (oros) hydromorphone in participants with cancer pain

Conditions: Pain

Summary: the purpose of this study is to evaluate the effectiveness and safety of osmotic release oral system (oros) hydromorphone using standardized conversion from prior opioid therapy among participants with cancer pain.

this is a prospective (study following participants forward in time), open-label (all people know the identity of the intervention), single-arm, multi-center (conducted in more than one center) study to evaluate the effectiveness and safety of stable dose of oros hydromorphone among participants with cancer pain. the duration of this study will be 28 days and will include visits at: day 0 (baseline), day 7, 14 and 28. the oros hydromorphone will be administered orally for 28 days and dose titration (incremental increase in drug dosage to a level that provides the optimal therapeutic effect) will be done every two days upon administration of dose. rescue medication (a medication intended to relieve symptoms immediately) of morphine will be permitted throughout the study duration. efficacy of the participants will primarily be evaluated by brief pain inventory score. participants' safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * participant with histological confirmed malignancy * participant on stable morphine or 25 milligram oxycodone dose equivalent per day. stable dose is defined as no dose change for 3 consecutive days and does not require more than 3 doses of rescue medication per day * life expectancy of at least 3 months * negative urine pregnancy test * participants with signed informed consent exclusion criteria: * participant intolerant or hypersensitive to hydromorphone or other opioid agonist * participant with unstable medical condition * participant with renal dysfunction and liver dysfunction * participant dependence to opiates * inability to take oral medication

Keywords: pain cancer osmotic release oral system oros hydromorphone jurnista
postpartum heparin against venous thromboembolism: a pilot randomized controlled trial

Conditions: Venous Thromboembolism

Summary: in previous attemps to answer the question of risk-benefit of postpartum thromboprophylaxis, researchers were faced with low recruitement rates. the goal of this pilot feasibility randomized controlled trial of postpartum pharmacological thromboprophylaxis is to examine the feasibility (recruitement rate) and participation rate at the geneva university hospitals


Eligibility criteria:
inclusion criteria: adult women within 48h of delivery, with: * ≥2 of the following risk factors age ≥35 years pre-pregnancy bmi 30.0-34.9kg/m2 current smoking elective cesarean section postpartum hemorrhage antenatal immobility * and/or ≥1 of the following risk factors: emergency cesarean section pre-pregnancy bmi ≥35kg/m2 known low-risk thrombophilia (heterozygous factor v leiden; heterozygous g20210 prothrombin mutation) pre-eclampsia pre-term delivery (\<37th week of gestation) peripartum systemic infection (defined as fever with use of antibiotics) intra-uterine growth restriction (birth weight \<5th percentile) exclusion criteria: * any indication for therapeutic anticoagulation * a high-risk of postpartum venous thromboembolism (personal history, high-risk thrombophilia) * an increased bleeding risk * a contra-indication to the use of heparin
efficacity of rtms in alcohol dependance

Conditions: Alcohol Dependance

Summary: prior research in substance dependence has suggested potential anti-craving effects of repetitive transcranial magnetic stimulation (rtms) when applied to the dorsolateral prefrontal cortex (dlpfc). the aim of the investigators study was to investigate the effect of high frequency rtms of the left dorsolateral prefrontal cortex compared to sham stimulation on craving and alcohol consumption.

prior research in substance dependence has suggested potential anti-craving effects of repetitive transcranial magnetic stimulation (rtms) when applied to the dorsolateral prefrontal cortex (dlpfc). the aim of our study was to investigate the effect of high frequency rtms of the left dorsolateral prefrontal cortex compared to sham stimulation on craving and alcohol consumption. 150 detoxified patients are randomized either to a high frequency rtms over the left dlpfc (n = 75) or a sham stimulations (n = 75). alcohol craving is determined with the obsessive compulsive drinking scale. patients are allocated to active and sham rtms in a 1: 1 ratio, such that 75 patients received active and 75 patients sham rtms to the left dlpfc (10 hz frequency, total 10 sessions). the alcohol craving questionnaire (acq-now) and the obsessive compulsive drinking scale (ocds) are administered to measure the severity of alcohol craving at baseline, after the last rtms session and day 15, m1, m3, m6 after. alcohol drinking is evaluated with timeline followback (tlfb).

Eligibility criteria:
inclusion criteria: * diagnosis of alcohol dependence syndrome according to dsm-iv criteria * detoxified inpatients hospitalised for alcohol withdrawal for more than one week * giving written informed exclusion criteria: * left-handed patients at the time of inclusion. * age \< 18 years * withdrawal assessment (ciwa-ar) scores of \> 5 * patients with major medical or neurological disorders or with a pacemaker or metal in any part of the body were excluded from the study.

Keywords: alcohol dependance rtms craving alcohol consumption
effectiveness of cervicothoracic manipulative treatment in unilateral shoulder impingement syndrome: a randomized controlled trial.

Conditions: Shoulder Pain; Manual Theapy; Exercises Therapy

Summary: the objective of this protocol is to compare degree of improvement can be achieved in patients with shoulder pain by treatment with manipulative techniques for the cervicothoracic spine versus home exercises.

design: randomized clinical trial. objective: to determine the effects of manipulative techniques for the ervicothoracic spine versus home exercises on pain, disability, and range of movement in patients with unilateral shoulder inmingement syndrome. methods and measures: ninety-two subjects will be randomly assigned to one of two groups. intervention: for 5-weeks, the groups 1 will undergo tratment comprising manipulative protocol techniques for the cervicothoracic spine (2/week) and the group 2 will develop a home exercise (2/week). main outcome measures: intensity of pain, disability, and range of motion data will be collected at baseline, and 24hr after the last therapy application. mixed-model analyses of variance will be used to examine the effects of the treatment on each outcome measure.

Eligibility criteria:
inclusion criteria: 1. report of pain or dysfunction with overhead activities 2. demonstration of pain during active shoulder movements 3. demonstration of a positive neer/hawkins-kennedy test 4. recent onset within the last 12 months 5. report of non-traumatic onset 6. demonstration of a painful arc of the arm from 60° to 120° of flexion 7. report of a baseline pain level of ≥2/10 on an 11 point numeric scale exclusion criteria: * the presence of any red flags * a history of frozen shoulder * disorders of the acromioclavicular joint * degenerative arthritis of the glenohumeral joint * known calcifying tendonitis (if identified by radiograph) * shoulder instability * posttraumatic disorders * shoulder surgery and/or elbow, hand, wrist and blatantly misdiagnosed cervical spine disorders

Keywords: shoulder pain shoulder impingement syndrome exercise therapy randomized controlled trial
comparing internet and in-person brief cognitive behavioral therapy of insomnia

Conditions: Insomnia

Summary: the objective of this study is to directly compare 6 sessions of in-person and internet administered cognitive-behavior therapy for insomnia (cbti) to a minimal contact control (mc), within an active duty military population to determine the comparative benefits of these interventions on improvement in sleep as well as domains strongly related to insomnia such as depression, substance abuse, and ptsd symptoms. a total of 189 military personnel with chronic insomnia, aged 18-65, will be recruited and randomized to receive 6-sessions (over 6 weeks) of cbti (n=77), icbti (n=35), or a mc control (n=77) condition. the investigators will compare these three groups on subjective and objective measures of sleep. the cbti and mc control groups will be compared on other variables of interest (e.g., depression, substance abuse, and ptsd symptoms) and predictors of outcomes.


Eligibility criteria:
inclusion criteria: * chronic insomnia as defined by research diagnostic criteria (rdc) criteria41 complaint of \> 3 months (chronic insomnia) of disturbed sleep \>3 nights/week (severe insomnia) as defined by at least one of the following as assessed by sleep diaries: sleep onset latency of \>30 min (initial insomnia) and/or wake after sleep-onset of \>30 min (middle insomnia) and/or early morning awakening of \>30 min before the desired wakeup time (late insomnia) and sleep efficiency \< 85% * active duty military member stationed at fort hood as assessed by self-report. * history of having deployed in support of oif or oef as assessed by self-report. • stable on psychotropic and/or hypnotic medications for at least one month as assessed by self-report and review of medical record.

Keywords: insomnia cognitive behavioral therapy internet depression substance use post-tramatic stress disorder
l-carnitine to treat fatigue in aids patients

Conditions: HIV Infections; AIDS

Summary: patients with aids may develop a deficiency of the micronutrient carnitine and such a deficiency may contribute to fatigue in these patients. this study will determine whether carnitine supplementation will improve fatigue and related symptoms in carnitine-deficient patients with aids.

fatigue is a commonly reported symptom in patients with end stage aids. appropriate treatment can relieve suffering and improve quality of life. the role of progression of the disease, depression, anemia, and poor nutritional status in the development of fatigue is well recognized. however, the impact of micronutrient deficiencies has been minimally explored. aids patients are at risk for micronutrient deficiencies because of decreased caloric intake, increased metabolic requirements, and treatment with medications that can interfere with absorption, synthesis, and excretion. patients with aids are particularly likely to be carnitine deficient. levocarnitine (l-carnitine) is a micronutrient found in meat and dairy products that plays a major role in energy metabolism. preliminary research has shown that patients with end stage aids experienced decreased levels of fatigue after l-carnitine supplementation. this study will evaluate the effectiveness of l-carnitine to treat patients with carnitine deficiency, fatigue, and aids. participants in this study will be randomly assigned to receive either l-carnitine or placebo for 2 weeks. to reduce the possibility of side effects, the doses of l-carnitine and placebo will be titrated over 6 days to the desired study dose. after 2 weeks, participants receiving placebo will be switched over to receive l-carnitine. all participants will continue on l-carnitine for an additional 2 weeks.

Eligibility criteria:
inclusion criteria: * aids at stage iv-c and estimated life expectancy \< 6 months * karnofsky performance score \> 50 * clinically significant, persistent fatigue * if undergoing pre-existing treatment for fatigue, must have been on a stable regimen for at least 4 weeks prior to study entry * concurrent use of epoetin alfa (procrit®) will be allowed if the patient has been on a stable dose of epoetin alfa for at least 60 days prior to study entry exclusion criteria: * severe cardiovascular, pulmonary, or renal function * hemodialysis * treatment or replacement therapy with any form of carnitine within 12 months prior to study entry * known sensitivity to carnitine * acute illness within 30 days of study entry that in the opinion of the study investigator would interfere with participation * active drug or alcohol use or dependence * history of any central nervous system disease involving the brain that may put the patient at risk for seizure (e.g., primary or metastatic brain tumor, stroke) or history of seizure * history of dementia, aphasia, or other deficits of cognition or speech/language function

Keywords: carnitine deficiency fatigue complementary therapies
microbiota changes in acute myeloid leukemia patients undergoing intensive chemotherapy

Conditions: Acute Myeloid Leukemia

Summary: this is a prospective, observational study to collect stool and blood from acute myeloid leukemia patients undergoing intensive chemotherapy.


Eligibility criteria:
inclusion criteria: * adults (ages 18 - 99 years) undergoing inpatient intensive chemotherapy for newly diagnosed, refractory, or relapsed aml. patients may or may not have been exposed to any type of therapy before. * any intensive chemotherapy regimen defined as a planned \~4 week inpatient stay. chemotherapy may be delivered for any number of days and on any schedule. patients may be discharged from the hospital sooner than 4 weeks if the treating physician choose so, but the expectation at the initiation of chemotherapy must be \~4 weeks of inpatient stay, as is typical. * able to provide written voluntary consent before performance of any study related procedure.

Keywords: aml
questionnaires in assessing attitudes about legalization of marijuana use in participants with cancer

Conditions: Malignant Neoplasm

Summary: this trial studies attitudes about legalization of marijuana use in participants with cancer. questionnaires may help doctors to learn about and compare the attitudes that patients in non-legalized and legalized states have towards the legalization of medical marijuana.

primary objectives: i. to compare the proportion of cancer patients' who have a positive attitude about legalizing marijuana for medical purposes between those in a legalized versus (vs.) a non-legalized state. secondary objectives: i. to evaluate the association of cancer patients' belief in the usefulness of medical marijuana in their state of residency (texas versus arizona). ii. to examine the association of demographic, physical and psychosocial characteristics of patients and their perception of medical marijuana. iii. to examine the preference of patients for treatment of pain, anxiety and depression between medical marijuana vs. opioids, anti-anxiety and anti-depressant medications. iv. to examine the association of media to perception of use of medical marijuana. v. to evaluate the association of cancer patients' attitude about legalizing marijuana for medical purposes vs. recreational purposes. vi. to examine the association of patients who have used marijuana for certain medical conditions/symptoms and their belief of how it has affected that condition/symptom. vii. to compare demographic, physical and psychosocial characteristics of patients who have used marijuana for medical purposes. viii. to compare demographic, physical and psychosocial characteristics of patients who have used marijuana for non-medical purposes. ix. to compare demographic, physical and psychosocial characteristics of patients who believe marijuana is useful for medical reasons. outline: participants complete 5 questionnaires.

Eligibility criteria:
inclusion criteria: * patients (inpatient or outpatient) seen by the palliative care team at banner md anderson or ut md anderson * patients able to speak and read english * patients enrolled in each site must be a resident of the state where that site is located (e.g. if a patient is enrolled at ut md anderson cancer center \[mdacc\], they should be resident of the state of texas) * patients should have a cancer diagnosis exclusion criteria: * patients who are not able to speak or read english * altered mental status as determined by the interviewer based on the ability to understand the nature of the study and consent process
quit for life (qfl): smoking cessation among chinese smokers living with hiv

Conditions: Smoking Cessation; HIV Infections

Summary: the purpose of this two arm randomized clinical trial (rct) is to test if a smoking cessation program called quit for life (qfl) which was developed by the investigators is effective for patients in china with hiv who smoke. this program is designed to suit the needs of people with hiv who smoke in china. eligible participants who provide consent will be randomized into either the qfl or the control group. the qfl group will receive a quit smoking program that lasts for 8 weeks with two parts- 1. 4 sessions with a trained counselor who will discuss the participants' smoking habits and strategies to help them quit. 2. messages sent to the participants' cell phone using wechat. the control group will not have sessions with a trained counselor or receive messages sent to their cell phone. both groups will be offered nicotine replacement therapy and a self-help guide with information about quitting smoking.


Eligibility criteria:
inclusion criteria: * hiv seropositive (by being at the hiv clinic and receiving care) * receiving art treatment from the clinic (by being at the hiv clinic and receiving care) * smokes ≥ 5 cigarettes per day * able to speak and read in mandarin chinese * self-reported anticipate to receive art treatment from the clinic for at least 9 months * own a cell phone * be willing to set a quit date within 1 month after baseline assessment exclusion criteria: * self-reported using other smoking cessation program or medication * having a serious health problem that may make them unsuitable to stay in the study

Keywords: quit for life (qfl) smoking cessation counselors wechat messages nicotine replacement therapy self-help smoking cessation guide people living with hiv/aids (plh)
par-4 and telomere-telomerase system in type 2 diabetes patients who received glp-1 or metformin treatment

Conditions: GLP-1；Metformin；Telomere-telomerase System；Par-4

Summary: objectives: to investigate the treatment effect between insulin,metformin and liraglutide; in type 2 diabetes in our hospital, in order to investigate the possible mechanism about telomere-telomerase system and par-4.

160 type 2 diabetes in our hospital will divide into 4 groups: group a (40 healthy volunteers), group b (40 patients who give basal and insulin treatment, group c（40 patients who give basal and liraglutide treatment),group d（40 patients who give basal and metformin treatment). the age, height, weight, blood glucose, glycosylated hemoglobin a1c（hba1c）,homeostasis model assessment(homa-ir), lipid, blood pressure, course of disease, telomere length,telomerase activity will record respectively. and high-sensitive c-reactive protein (hscrp), par-4, gst,sod,gsh-px,atf-6,chop,xbp-1 and tumor necrosis factor-α（tnf-α） will detect as baseline. after each group's treatment, change from baseline of all indexes will record, multifactor logistic regression will be analyzed the correlations between each positive indexes.

Eligibility criteria:
inclusion criteria: * newly dignosised type 2 diabetes according to who criteria.glycated hemoglobin (hba1c) was more than 10%; * seronegative for antibodies against insulin, islet cells and glutamic acid decarboxylase (gad); exclusion criteria: * type 1 diabetes mellitus,presence of autoimmune diabetes indicated by antibodies to insulin, islet cells, and gad； * gestational diabetes; * patients with heart, liver, or renal function impairment;presence of severe infections or cerebrovascular disease;

Keywords: telomere-telomerase par-4 glp-1 metformin
prevention of infection and incidence of covid-19 in medical personnel assisting patients with new coronavirus disease

Conditions: Increased Risk of SARS-CoV-2 Infection

Summary: this is a randomized controlled trial of the efficacy and safety evaluation of oral administration of bromhexine hydrochloride for the prevention of sars-cov-2 infection and covid-19 disease in medical personnel assisting patients with a new coronavirus disease

this study aims to evaluate the oral administration of bromhexine hydrochloride for the prevention of sars-cov-2 infection and covid-19 disease in medical personnel assisting patients with a new coronavirus disease. the aim of the study is to determine the preventive role of this drug in the framework of reducing the incidence of coronavirus infection in risk groups (medical personnel). several studies show, that the acute respiratory syndrome coronavirus sars-cov uses endosomal cysteine proteases cathepsin b and l (catb/l) and the transmembrane protease serine type 2 (tmprss2) for the priming of the viral s-protein. the new coronavirus sars-cov-2 penetrates into alveolar epithelial type two cells through a similar mechanism. in detail, viral s-protein binds to pneumocyte angiotensin-converting enzyme 2 (ace2) and then undergoes cleaving by tmprss2 in s1- and s2-subunits. this leads to the release of a fusion peptide, which allows the virus to enter the cell via endocytosis. therefore, the protease tmprss2 can serve as a target for pharmacological agents to prevent the penetration of the sars-cov-2 into the cell. bromhexine blocks the tmprss2 ability to activate a zymogen precursor of tissue plasminogen activator in vitro. interestingly, tmprss2 is blocked by much lower concentrations then required to inactivate other proteases in the cell culture. however, these data cannot be simply extended to the clinical practice: whether the concentration of bromhexine in the lung tissue of properly treated patients would be enough to prevent the virus entry through the tmprss2-inactivation remains unclear. a randomized study in people at risk for coronavirus infection will clarify the role of bromhexine hydrochloride as a prevention of this disease.

Eligibility criteria:
inclusion criteria: 1. age of 18 years or more; 2. negative test (pcr) for sars-cov-2 infection; 3. the absence of clinical manifestations of a respiratory infection; 4. contact with patients with laboratory and / or clinically confirmed sars-cov-2 infection; 5. signed informed consent to participate in the study. exclusion criteria: 1. intolerance to bromhexine hydrochloride; 2. work out of contact with sars-cov-2 infection; 3. non-compliance with the rules for the use of personal protective equipment when working with sars-cov-2 infection (the rules for the use of personal protective equipment in accordance with the recommendations of the ministry of health of russia and the internal orders of the director general of almazov nmrc, relevant to the dates of research); 4. pregnancy and the period of breastfeeding; 5. other circumstances that the researcher considers inappropriate to participate in this study
efficacy study of gemcitabine-paclitaxel to treat metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: the purpose of this study is to determine the response rate to a gemcitabine-paclitaxel combination administered on a 3-weekly schedule in chinese patients with unresectable, locally recurrent breast cancer or metastatic breast cancer.


Eligibility criteria:
inclusion criteria: * female patients of chinese origin with histologically or cytologically proven diagnosis of breast cancer. * unresectable, locally recurrent breast cancer or stage iv disease. * have at least one measurable lesion as defined by response evaluation criteria in solid tumors (recist) criteria. * performance status of 0 or 1 on the eastern cooperative oncology group (ecog) scale * treatment with an anthracycline-based chemotherapy regimen in the adjuvant/neoadjuvant setting with subsequent disease relapse. exclusion criteria: * prior chemotherapy for unresectable, locally advanced breast cancer or metastatic disease. * concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy. * known or suspected brain metastasis or second primary malignancy that is clinically detectable at the time of consideration for study enrollment. * active infection or other serious condition. * pregnant or breastfeeding.